Metreleptin is a leptin analog indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in subjects with congenital or acquired generalized lipodystrophy. Congenital generalized lipodystrophy is a rare condition characterized by an almost total lack of adipose tissue in the body and a very muscular appearance. Adipose tissue is found in many parts of the body, including beneath the skin and surrounding the internal organs. It stores fat for energy and also cushions and insulates the body. A shortage of adipose tissue leads to the storage of fat elsewhere in the body, such as in the liver and muscles, which causes serious health problems. Acquired generalized lipodystrophy is a rare condition that appears during childhood or adolescence, characterized by fat loss affecting large areas of the body, particularly the face, arms, and legs.
In addition, metreleptin is being investigated as a treatment for other indications, including partial lipodystrophy, hypothalamic amenorrhea, nonalcoholic steatohepatitis, and various other hypoleptinemic dysmetabolic disorders.
Metreleptin is generally administered via daily subcutaneous injection. Because of this repeated administration, there is a risk that subjects may develop antibodies to metreleptin. These antibodies may neutralize metreleptin, rendering the treatment ineffective. What is more, they may neutralize endogenous leptin, worsening the disease of subjects already suffering from leptin deficiency. For this reason there is a need in the art of a method of reliably detecting neutralizing antibodies in subjects.